MAUDE Adverse Event Report: REYNOSA MANUFACTURING CUSTOM COMBI SET

Catalog Number 03-2722-9

Device Problem Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2015

Event Type  malfunction  

Event Description

A user facility reported during treatment, the machine alarmed "high arterial pressure" due to kinked arterial and venous bloodlines.The patient was set up with new supplies and completed treatment without any further issues.No adverse events or ill effects were experienced as a result.The sample was available for manufacturer evaluation and has been requested.

Manufacturer Narrative

Plant investigation has not yet been completed.A follow up report will be filed upon completion of the investigation.

Manufacturer Narrative

The actual device was returned to the manufacturer for physical evaluation and the complaint is not confirmed.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.

• Brand Name: CUSTOM COMBI SET
• Manufacturer (Section D): REYNOSA MANUFACTURING; reynosa ; MX
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter street; waltham, MA 02451-1457
• MDR Report Key: 4890805
• MDR Text Key: 15589007
• Report Number: 8030665-2015-00316
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2017
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 14SR01100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008K2 HEMODIALYSIS MACHINE
• Patient Age: 52Y
• Patient Weight: 57